Menu
Recruiting NCT06943586

Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing

No phase Interventional Stroke Transient Ischemic Attack (TIA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy).
Who it may be relevant to
Registry conditions: Stroke, Transient Ischemic Attack (TIA). Basic parameters: 18 years — 89 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Pharmacogenomics in Stroke: Feasibility of CYP2C19 Testing in Patients With Minor Stroke or High Risk TIA (CYP2C19 and Stroke)

Overview

The purpose of this research study is to explore whether genetic testing can offer a personalized and timely approach to assist physicians in making more informed medication decisions for stroke or high-risk transient ischemic attack (TIA) patients during their hospital stay.

Detailed description

This is a pilot clinical trial for feasibility

Interventions

  • Genetic CYP2C19 Genotype Guided DAPT (dual antiplatelet therapy)
    CYP2C19 is a gene that encodes an enzyme responsible for metabolizing several medications, including the antiplatelet drugs.

Primary outcome measures

  • Stroke participant feasibility of return of CYP2C19 genetic testing results [Time frame: 6 hours from buccal swab collection]
Secondary outcome measures (1)
  • Recurrent stroke, TIA, major bleeding and Modified Rankin Scale at ~90days [Time frame: 90 days following stroke]

Eligibility criteria

Inclusion criteria

  • Patients 18-89 years of age
  • admitted to University of Alabama at Birmingham (UAB) main hospital with symptoms or signs of minor ischemic stroke, or high risk TIA
  • eligible to receive dual antiplatelet load (presented to the hospital within 66 hours of last known well)

Exclusion criteria

  • diagnosis of atrial fibrillation, valvular heart disease, index stroke due to known hypercoagulability (subset of other determined etiology) or large vessel disease (culprit vessel stenosis of ≥50%)
  • prescribed anticoagulation prior to stroke
  • treated with intravenous thrombolysis
  • treated with mechanical thrombectomy
  • missing NIH Stroke Scale score

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Health services research

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Publications

  • Nordeen JD, Patel AV, Darracott RM, Johns GS, Taussky P, Tawk RG, Miller DA, Freeman WD, Hanel RA. Clopidogrel Resistance by P2Y12 Platelet Function Testing in Patients Undergoing Neuroendovascular Procedures: Incidence of Ischemic and Hemorrhagic Complications. J Vasc Interv Neurol. 2013 Jun;6(1):26-34. PMID 23826440
  • Meschia JF, Walton RL, Farrugia LP, Ross OA, Elm JJ, Farrant M, Meurer WJ, Lindblad AS, Barsan W, Ching M, Gentile N, Ross M, Nahab F, Easton JD, Kim AS, Zurita KG, Cucchiara B, Johnston SC. Efficacy of Clopidogrel for Prevention of Stroke Based on CYP2C19 Allele Status in the POINT Trial. Stroke. 2020 Jul;51(7):2058-2065. doi: 10.1161/STROKEAHA.119.028713. Epub 2020 Jun 17. PMID 32568642
  • Wang Y, Meng X, Wang A, Xie X, Pan Y, Johnston SC, Li H, Bath PM, Dong Q, Xu A, Jing J, Lin J, Niu S, Wang Y, Zhao X, Li Z, Jiang Y, Li W, Liu L, Xu J, Chang L, Wang L, Zhuang X, Zhao J, Feng Y, Man H, Li G, Wang B; CHANCE-2 Investigators. Ticagrelor versus Clopidogrel in CYP2C19 Loss-of-Function Carriers with Stroke or TIA. N Engl J Med. 2021 Dec 30;385(27):2520-2530. doi: 10.1056/NEJMoa2111749. PMID 34708996
  • Pereira NL, Cresci S, Angiolillo DJ, Batchelor W, Capers Q 4th, Cavallari LH, Leifer D, Luzum JA, Roden DM, Stellos K, Turrise SL, Tuteja S; American Heart Association Professional/Public Education and Publications Committee of the Council on Genomic and Precision Medicine; Council on Arteriosclerosis, Thrombosis and Vascular Biology; Council on Cardiovascular and Stroke Nursing; Council on Clinic PMID 38899464
  • Prevention: Cfdca. Centers for disease control and prevention: Stroke. Accessed May 18, 2023

Identifiers

NCT: NCT06943586 · IRB-300013920 · MULTIPI8165

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗